NCT02767544

Brief Summary

In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain and need of oxycodone.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable postoperative-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

May 2, 2016

Last Update Submit

May 9, 2016

Conditions

Postoperative Pain

Keywords

laparoscopic hysterectomypostoperative painlocal analgesiavaginal wound

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores

    Visual Analog Score (VAS) for pain. Physicians Global Assessment to measure quality of pain. 10-point VAS score for pain (0-10), 0 indicating no pain and 10 indicating unbearable pain at 1,3,6,12 and 24 h (hour) after surgery (Units on a Scale; 0-10).

    Change in 24 hours after surgery

Secondary Outcomes (5)

  • Complication

    Up to one week

  • Nausea

    Change in 24 hours after surgery.

  • Length of hospitalisation

    Up to one week

  • The use of analgesics for postoperative pain

    Change in 24 hours after surgery

  • Vomiting

    Change in 24 hours after surgery.

Study Arms (2)

ropivacaine group

EXPERIMENTAL

Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

Procedure: Vaginal wound local analgesia after laparoscopic hysterectomy

Control group

NO INTERVENTION

Vaginal wound no local analgesia by 10 ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

Interventions

Vaginal wound local analgesia after laparoscopic hysterectomyPROCEDURE
ropivacaine group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.

    PMID: 17507163BACKGROUND

  • Brummer TH, Jalkanen J, Fraser J, Heikkinen AM, Kauko M, Makinen J, Puistola U, Sjoberg J, Tomas E, Harkki P. FINHYST 2006--national prospective 1-year survey of 5,279 hysterectomies. Hum Reprod. 2009 Oct;24(10):2515-22. doi: 10.1093/humrep/dep229. Epub 2009 Jul 10.

    PMID: 19592483BACKGROUND

  • Hristovska AM, Kristensen BB, Rasmussen MA, Rasmussen YH, Elving LB, Nielsen CV, Kehlet H. Effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy: a randomized, placebo-controlled trial. Acta Obstet Gynecol Scand. 2014 Mar;93(3):233-8. doi: 10.1111/aogs.12319.

    PMID: 24576202BACKGROUND

  • Beaussier M, Bouaziz H, Aubrun F, Belbachir A, Binhas M, Bloc S, Fuzier R, Jochum D, Nouette-Gaulain K, Paqueron X; membres du comite douleur-ALR de Sfar. [Wound infiltration with local anesthetics for postoperative analgesia. Results of a national survey about its practice in France]. Ann Fr Anesth Reanim. 2012 Feb;31(2):120-5. doi: 10.1016/j.annfar.2011.10.017. Epub 2011 Dec 29. French.

    PMID: 22209702BACKGROUND

  • Kato J, Ogawa S, Katz J, Nagai H, Kashiwazaki M, Saeki H, Suzuki H. Effects of presurgical local infiltration of bupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecologic examinations: a possible preemptive analgesic effect. Clin J Pain. 2000 Mar;16(1):12-7. doi: 10.1097/00002508-200003000-00003.

    PMID: 10741813BACKGROUND

  • Kahokehr A, Sammour T, Srinivasa S, Hill AG. Systematic review and meta-analysis of intraperitoneal local anaesthetic for pain reduction after laparoscopic gastric procedures. Br J Surg. 2011 Jan;98(1):29-36. doi: 10.1002/bjs.7293.

    PMID: 20979101BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Päivi I Pakarinen, MD PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 10, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share